MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZTA-D-28-160-W1

Device Problems Material Frayed (1262); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Similar to device under pma/510(k) p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: patient's access route had some narrowing and tortuosity but diameter of the access route was more than 7mm and patient's anatomy was suitable for using zta-d-28-160-w1.Access was gained from the right femoral artery and zta-d-28-160-w1/lot e3860282 advanced over cook's lunderquist double curved wire guide but the delivery system got caught by the leg endoprosthesis (from another manufacturer) at the common iliac artery and advancing the delivery system was difficult.The user removed the delivery system from the body.The user confirmed that the tip of the delivery system was frayed and compressed, therefore he stopped using the device to avoid the risk of damaging patient anatomy.Then, 20fr sheath from another manufacturer was successfully advanced in the endoprosthesis from another manufacturer, so thoracic endoprosthesis from another manufacturer was placed.During the delivery of zta and introducer sheath from another manufacturer, the leg endoprosthesis may have been pushed up, so additional leg endoprosthesis from another manufacturer was placed until the extenal iliac artery and the procedure was completed.Patient outcome: there have been no adverse effects to the patient reported.

Manufacturer Narrative

Manufacturer ref# (b)(4).After investigation the event for this pr# is no longer reportable.Summary of investigational findings: a 80 year old female patient underwent surgery for taa using zta-d-28-160-w1 (complaint device).The patient previously had a gore excluder placed for aaa.Access was gained from the right femoral artery and the zta-28-160-w1 was advanced over cook's lunderquist double curved wire guide.However, the delivery system got caught by the excluder leg at the cia and the advancement of the delivery system was difficult.When the physician removed the delivery system it was confirmed that the tip of the sheath was frayed and the sheath was compressed.The zta-d-28-160-w1 was replaced by a gore stent-graft and the procedure was completed.The patient had some narrowing and tortuosity of the access route, but the diameter of the access route was more then 7mm so the patient was considered suitable for the procedure.There have been no adverse effects to the patient reported.No product was returned.A photo of the damaged sheath tip was provided.The photo shows fraying at the sheath tip and compression of the sheath.According to the description of event it is likely that the fraying and compression of the sheath was caused by the delivery system getting caught by the excluder leg, however an exact cause of the event cannot be determined based on the provided information.The ifu recommends: do not continue advancing the wire guide or any portion of the introduction system if resistance is felt.Stop and assess the cause of resistance; vessel, catheter, or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis, or calcified or tortuous vessels.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8854101
• MDR Text Key: 158873846
• Report Number: 3002808486-2019-01100
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002448763
• UDI-Public: (01)10827002448763(17)220611(10)E3860282
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2022
• Device Catalogue Number: ZTA-D-28-160-W1
• Device Lot Number: E3860282
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 08/02/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 42